Self-Management for Head and Neck Lymphedema and Fibrosis [PROMISE Trial]

Part of paid clinical trials in Philadelphia, Pennsylvania.

Sponsor
Abramson Cancer Center at Penn Medicine
Study ID
NCT06125743
Status
Recruiting
Apply to this trial

Conditions

  • Lymphedema of the Head and Neck

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Usual Care — BEHAVIORAL
    Participants will conduct self-care activities prescribed by their treating lymphedema therapists.
  • In-Person LEF-SMP — BEHAVIORAL
    Participants will receive the in-person LEF-SMP intervention.
  • Telehealth LEF-SMP — BEHAVIORAL
    Participants will receive the telehealth LEF-SMP intervention.

Study Details

The goal of this study is to evaluate the effectiveness of a standardized lymphedema and fibrosis self-management program (LEF-SMP) to improve LEF self-management and reduce LEF-associated symptom burden, functional deficits, and improve quality of life in head and neck cancer (HNC) survivors.

Key Dates

Start date
Mar 29, 2024
Status verified
Aug 2025
Primary completion
Aug 31, 2026
Completion
Aug 31, 2026

Study Design

Enrollment
204 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE

Arms

  • Other: Usual Care
  • Experimental: In-Person LEF-SMP
  • Experimental: Telehealth LEF-SMP

Primary Outcome Measure

Changes in severity of lymphedema and fibrosis [ Time Frame: Baseline, 3-, 6-, and 9-months post-intervention ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
University of PennsylvaniaPhiladelphiaPennsylvania19104
Jie Deng, PhD
[email protected]
215-573-2393
Barbara MurphyNashvilleTennessee37232
Barbara Murphy, MD

Find similar trials in Philadelphia, PA

By research site
University of Pennsylvania· Philadelphia, PABarbara Murphy· Nashville, TN

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